Cue Health received FDA emergency use authorization for its at-home and over-the-counter test on March 5.
The Cue Health COVID-19 Test for Home and Over The Counter (OTC) use is a molecular nucleic acid amplification test (NAAT) designed to detect genetic material from the SARS-CoV-2 virus in the nostrils. The FDA authorized it for use by symptomatic and asymptomatic people, adults and children aged 2 and older with adult assistance.
The Cue OTC test cartridge pack has a single-use, self-contained test cartridge and a swab used for minimally invasive nasal sample collection. All of the components make up the Cue Health monitoring system for a clinical-grade test at home or a non-clinical setting.
The home/over-the-counter test detects the RNA of SARS-CoV-2 with the same accuracy as a central lab test, according to Cue Health. It runs on the rechargeable Cue cartridge reader, a reusable device that fits in the palm of the hand. The results from the test are displayed in 20 minutes to a user’s mobile smart device through the Cue Health app.
In prospective studies, the Cue OTC test produced results that were 97.4% agreement for positive cases and 99.1% agreement for negative cases compared to results from a highly sensitive EUA PCR laboratory-based test, according to the San Diego-based company.